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Business Wire Health: FDA News
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Last updated 1 day ago
Enigma Biomedical USA Announces FDA Approval of TAUKLARIFY™ (florquinitau F 18 injection) for Use in Patients Being Evaluated for Alzheimer’s Disease
1 day ago
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Enigma Biomedical USA (EB USA) today announced the U.S. Food...
Lantern Pharma Reports Second Quarter 2026 Financial Results and Provides Business Update
1 day ago
DALLAS--(BUSINESS WIRE)--Lantern Pharma Reports Second Quarter 2026 Financial Results and Provides Business...
U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse
1 day ago
PRINCETON, N.J.--(BUSINESS WIRE)---- $BMY #CELMoD--U.S. FDA Grants Accelerated Approval to Bristol Myers...
Gossamer Bio Announces Second Quarter 2026 Financial Results and Provides Business Update
1 day ago
SAN DIEGO--(BUSINESS WIRE)---- $GOSS--Gossamer Bio, Inc. (Nasdaq: GOSS) (the “Company” or “Gossamer”)...
Zoetis Receives Emergency Use Authorization for Simparica Trio® (sarolaner, moxidectin, and pyrantel chewable tablets) for Treatment of New World Screwworm Infestations in Dogs and Puppies
1 day ago
PARSIPPANY, N.J.--(BUSINESS WIRE)---- $ZTS #animalhealth--Zoetis Inc. today announced that Simparica Trio has...
PhenoNet Cleared by FDA to Begin Phase 3 Trial of Inhaled PHENOGENE-1A in Early Alzheimer's Disease
2 days ago
CAMBRIDGE, Mass.--(BUSINESS WIRE)--FDA clears PhenoNet Inc. to advance PHENOGENE-1A into Phase 3...
Cadence’s HypertensionOS Software Announced as Second Participant in FDA’s TEMPO to Advance Hypertension Care
2 days ago
NEW YORK--(BUSINESS WIRE)--Cadence, the clinical AI company automating the treatment of chronic...
Cure Sanfilippo Foundation and National MPS Society Make $5.5 Million Strategic Investment in Spruce Biosciences
3 days ago
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB) a late-stage biopharmaceutical...
New Survey Finds U.S. Biotechs Advancing Treatments for Rare and Serious Diseases Want to Run Clinical Trials in U.S. but Regulatory Hurdles are Sending Them Abroad
3 days ago
CAMBRIDGE, Mass.--(BUSINESS WIRE)--A new survey reveals that U.S. biotechnology companies focused on...
Definium Therapeutics Announces Positive Topline Results from Phase 3 Voyage Study of DT120 ODT in Generalized Anxiety Disorder
3 days ago
NEW YORK--(BUSINESS WIRE)--Definium Therapeutics, Inc. (Nasdaq: DFTX) ("Definium" or the "Company"), a...
Owlet Announces Second Quarter 2026 Financial Results
4 days ago
LEHI, Utah--(BUSINESS WIRE)---- $owlt #babymonitor--Owlet, Inc. (“Owlet” or the “Company”) (NYSE: OWLT)...
NDI Notification Filed with FDA for NMN Supplied by Nutrition BioTech
4 days ago
POMONA, Calif.--(BUSINESS WIRE)--The nicotinamide mononucleotide (NMN, CAS 1094-61-7) supplied by Nutrition BioTech...